Services

Clinical Data Analytics Services

A plethora of technologies and the ever-increasing complexity, volume, regulatory requirements and geographic spread of clinical trials is forcing companies to examine their core focus areas, while encouraging them to outsource clinical data management, SAS programming and biostatistics to a trusted partner. With the primary focus of a biopharmaceutical company or a CRO being science and research, they need a versatile technology organization with clinical research expertise to take care of all their data management, clinical programming and IT needs without incurring additional fixed costs. They also look for supporting partners who need to be responsive and can ramp up and down to meet the peaks and valleys of work load, at a reasonable cost while ensuring high quality working in regulated environments.

Our Capabilities

KVRA Tech provides flexible and scalable engagement models to manage your Biostatistics and SAS Programming staffing and outsourcing needs. These models assure quality services, constant communication, improved efficiencies and up to 15% - 40% cost savings. We offer wide range of expertise in all phases of clinical trials (I-IV), with pool of expert statisticians and statistical programmers holding advanced degrees and having a strong exposure to various therapeutic areas. Our team works with the end goal in mind, which is the timely submission of results from various clinical stages in order to support regulatory review, approval and monitoring of patient safety.

SAS Programming:

  • Standardized approach for analysis files
  • Transportable tools to support standard non-efficacy reports
  • Programming based on analysis data
  • Independent quality reviews
  • Customized clinical data outputs
  • Proactive, results-oriented approach to programming
  • Preparation of Case Report Tabulations (CRT) for submission
  • Programming based on data validation plan
  • Programming of tables/listings/figures for clinical study report and data monitoring committee
  • Programming for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)


CDISC Services:

  • Ensure accurate interpretation of the Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM)
  • Annotate Case Report Forms (CRFs) as per SDTM standards
  • Create mapping specification for SDTM domains
  • Create dataset specifications for ADaM datasets
  • Convert datasets from legacy studies to SDTM


Biostatistics:

  • Consultation on study design
  • Protocol development
  • Randomization
  • Statistical Analysis Plan (SAP)
  • Interim analysis
  • DSMB participation
  • Sample size calculations

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